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Posted 3h ago•US Remote
Manager of Statistical Programming
MiddleRemoteSalary undisclosed
Required Skills
GCP
Job Description
This is an exciting opportunity to participate in advancing Natera’s oncology product portfolio of cutting-edge diagnostic tests. As Manager of Statistical Programming, you will leverage your strong R programming skills and clinical trials background to contribute to the analysis and reporting of clinical trials supporting multiple regulatory submissions.
Primary Responsibilities:
- Lead and oversee statistical programming deliverables, including ADS (Analysis Datasets) and TLF (Table, Listings and Figures), ensuring data integrity and regulatory compliance with ICH, GCP, and FDA 21 CFR Part 11.
- May manage a team of statistical programmers, taking responsibility for their technical and professional development, while contributing hands-on to programming work.
- Act as primary programming lead for regulatory submissions (e.g., 510(k), CTA/CDx, and PMA), ensuring all deliverables meet rigorous global standards.
- Maintain programming infrastructure, including R package development, validation, and maintenance in a controlled environment.
- Develop R Shiny dashboards that support data review, study monitoring,
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